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Fore Biotherapeutics · 1 month ago

Associate Director, Regulatory Project Management & Operations

Philadelphia, PA, US

Full-time

Onsite

Lead/Staff, Director/Executive

8+ years exp

Fore Biotherapeutics is seeking an experienced and highly motivated regulatory project management professional to support the Registration & Launch of plixorafenib. The AD, Regulatory Project Management & Operations will work alongside the Regulatory and Launch Readiness team to translate regulatory and Launch strategy into project plans.

BiotechnologyHealth CareHealth DiagnosticsMedicalOncology

Responsibilities

Collaboratively partner with cross functional team members from key functional areas including Regulatory, Business Development, Commercial Launch, Quality, Clinical and Safety to develop and execute integrated registration and launch project plan in alignment with end-to-end program plans

Maintain cross-functional project plans, in collaboration with each functional lead, and provide routine updates on performance to plan to be included in dashboards to leadership

Responsible for driving collaboration for the development of the overall Regulatory, BD, and Launch strategy, including documentation and communication of decisions, actions, and risks

Ensure timely communication of changes in program strategy, issues and risks to team members and other functional areas as appropriate, including monitoring key deliverables, decision points, project milestones, demand planning, and critical path activities to drive delivery of project objectives

Develop agendas for meetings and produce high quality meeting minutes (including decisions, risks, next steps) and related outputs to monitor program status

Work collaboratively with the Team Leaders and functional leaders to track the critical operational aspects of the program(s) and ensure positive team spirit and high functioning team

Facilitate the management of risk by scheduling meetings with the teams as appropriate. Responsible for identifying risks and supporting the development of risk mitigation plans

Synthesize numerous sources of data and key analysis translating into specific actions to support company strategy

Participate in development of Project Management tools, templates and processes. Implement best practices and tools across teams e.g., project initiation meetings, resource capacity planning, risk management, team performance, and timeline development

Responsible for managing regulatory files and coordinating regulatory operations (plans for regulatory filings, document publishing, transmission) with vendor

Qualification

Regulatory project managementFDA CDER protocolsNDA submission experienceOncology experienceProject Management toolsPMP certificationMicrosoft ProjectTechnical writingInterpersonal communicationOrganizational skills

Required

BS, BA or equivalent in life sciences or health-related field and at least 8 years of relevant industry experience

Proven experience with FDA Center for Drug Evaluation and Research (CDER) protocols and guidelines as well as overall understanding and knowledge of IND application filing process

Experience with mid to late-stage clinical program management across all functions

Demonstrated experience in supporting programs through NDA submission and commercial launch

Outstanding organizational skills

Detail oriented

Proven ability to excel in a matrix environment

Strong record of attention to detail without losing sight of the larger goals

Ability to multi-task and handle multiple projects simultaneously

Strong project management, business process management, and optimization skills

Effective record keeping and presentation skills (including the ability to develop clear and concise presentations) are required

Has an established broad working knowledge of core pharmaceutical disciplines, including clinical development, regulatory affairs, manufacturing, translational medicine and intellectual property

Demonstrates advanced team facilitation skills that consistently foster effective brainstorming and decision making with both internal colleagues and vendors, particularly in a startup environment

Excellent technical writing, oral, presentation, and interpersonal communication skills

Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company